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Cephalexin 250 mg/5mL For Suspension, 100 mL — NDC 70518-4511-0 (Billing 70518-4511-00)

by REMEDYREPACK INC. · 100 mL in 1 BOTTLE

This is a package of 100 mL of Cephalexin 250 mg/5mL For Suspension from REMEDYREPACK INC., marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 70518-4511-00
🏷️ FDA NDC (as labeled) 70518-4511-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70518-4511-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70518 labeler · 4511 product · 0 package
Package marketed since
Oct 28, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7051845110 7
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Cephalexin (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0469-2025
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0468-2025
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g (Bryant Ranch Prepack, Inc.) · FDA recall D-0537-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0539-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0538-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0540-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-4511-0
Product NDC 70518-4511
11-digit billing NDC 70518451100
Application # ANDA210221
SPL Set ID 5b870337-c133-dd79-e063-6394a90a03ef
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-28
Route ORAL
Dosage form FOR SUSPENSION
Substance CEPHALEXIN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-4511-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-4511-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📖 What it is MedlinePlus · NLM

Cephalexin is used to treat certain infections caused by bacteria. Cephalexin is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cephalexin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cephalexin is an antibiotic used to treat bacterial infections — things like strep throat and other respiratory infections, ear infections, skin infections, bone infections, and ur...
  • Yes, you can take cephalexin with or without food — it's stable in stomach acid either way. If it upsets your stomach, taking it with a small meal or snack can help. Just try to ta...
  • The most common side effects are stomach-related — diarrhea, nausea, vomiting, or indigestion. These are usually mild and manageable. The ones to call your doctor about are: a seve...
  • What side effects should I watch out for?
📖 Read our full Cephalexin guide →
7
Nutrient depletion considerations

Cephalexin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cephalexin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1952 $19.52 / 100 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-4511-00 You're viewing this Main listing 100 mL in 1 BOTTLE 2025-10-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cephalexin 250 mg/5mL 67877-0545-68 Ascend 200 ml $0.050 AB Availability likely —
Cephalexin 250 mg/5mL 00093-4177-73 Teva 100 ml $0.071 AB Discontinued —
Cephalexin 250 mg/5mL 59651-0323-01 Aurobindo 100 ml $0.071 AB Availability likely —
Cephalexin 250 mg/5mL 62135-0481-42 Chartwell 100 ml $0.071 AB Availability likely —
cephalexin 250 mg/5mL 68180-0441-01 Lupin 100 ml $0.071 AB Availability likely —
Cephalexin 250 mg/5mL 50090-4795-00 A-S 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 50090-5196-00 A-S 100 ml — AB FDA listed —
cephalexin 250 mg/5mL 50090-6445-00 A-S 100 ml — AB FDA listed —
cephalexin 250 mg/5mL 50090-7091-00 A-S 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 63187-0205-00 Proficient 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 63629-8857-01 Bryant 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 63629-8858-01 Bryant 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 63629-9206-01 Bryant 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 63629-9207-01 Bryant 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 66267-0982-00 NuCare 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 68071-2889-02 NuCare 200 ml — AB FDA listed —
cephalexin 250 mg/5mL 68071-3587-02 NuCare 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 68071-5038-00 NuCare 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 68788-7529-01 Preferred 100 ml — AB FDA listed —
cephalexin 250 mg/5mL 68788-8686-02 Preferred 200 ml — AB FDA listed —
Cephalexin 250 mg/5mLthis 70518-4511-00 REMEDYREPACK 100 ml — AB FDA listed —
cephalexin 250 mg/5mL 71205-0553-00 Proficient 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 71335-2734-01 Bryant 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 71335-2877-01 Bryant 200 ml — AB FDA listed —
Cephalexin 250 mg/5mL 71335-2986-01 Bryant 100 ml — AB FDA listed —
Cephalexin 250 mg/5mL 72162-1851-01 Bryant 100 ml — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Cephalexin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderALKEM LABORATORIES LTD
FDA applicationANDA210221 (ANDA)
Labeler code70518
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio1,529 products on file

More NDCs from REMEDYREPACK INC. labeler code 70518

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cephalexin — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cephalexin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.31M
Claims incl. refills
1.8M
Beneficiaries
1.6M
Spend / beneficiary
$8.47
Spend / claim
$7.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70518-4510-00 · REMEDYREPACK 70518-4512-00 · REMEDYREPACK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.